(22 days)
Not Found
No
The device description focuses on the chemical and physical properties of the hemostatic agent and its delivery mechanism (mesh bag). There is no mention of any computational or algorithmic processes, let alone AI/ML. The performance studies are in-vivo animal tests, not related to training or evaluating an AI/ML model.
Yes
The device is intended to treat external traumatic wounds by achieving hemostasis and preventing blood loss, which is a therapeutic function.
No
Explanation: The device description clearly states that QuikClot ACS is intended for "emergency use only as an external traumatic wound treatment to achieve hemostasis for moderate to severe bleeding." Its mechanism of action involves accelerating natural clotting processes and increasing temperature at the wound site, which are therapeutic actions, not diagnostic ones. There is no mention of the device being used to identify, detect, or monitor any medical condition or disease.
No
The device description clearly describes a physical product consisting of mesh bags containing zeolite beads, intended for external application to wounds. It does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for emergency use only as an external traumatic wound treatment to achieve hemostasis for moderate to severe bleeding." This describes a device applied directly to a wound on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a material (zeolite beads in a mesh bag) that interacts directly with blood at the wound site to promote clotting. It does not describe a test or assay performed on a biological sample.
- Mechanism of Action: The mechanism involves physical and chemical interactions with blood at the wound site (adsorbing water, concentrating clotting factors, increasing temperature), not an analysis of a biological sample.
- Anatomical Site: The anatomical site is an "external traumatic wound," indicating application to the body's surface.
- Performance Studies: The performance studies are described as "In-Vivo testing on swine," which involves testing on living organisms, not in vitro testing on biological samples.
IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to directly treat a wound on the body.
N/A
Intended Use / Indications for Use
QuikClot ACS - "Advanced Clotting Sponge" ™, is intended for emergency use only as an external traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
The new mesh bags containing beads of QuikClot® Brand Hemostatic Agent, also called QuikClot ACS™ - "Advanced Clotting Sponge", are intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss.
The beads inside the mesh bags consist of a synthetic molecular sieve (zeolite) that accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site. Individual sieve particles of the hemostatic agent adsorb water molecules. As the water is removed from the blood, the platelets and clotting factors are concentrated. The platelets have been activated by the normal response to injury. This adsorption process is exothermic. The resultant increase in temperature at the site of application increases the rate of the clotting reactions and platelet aggregation and adhesion.
Both of the mechanisms described above, concentration of clotting factors and the increase in rates of platelet aggregation/adhesion, work together to increase the clotting rate. This would be consistent with what is known about the effects of temperature and concentration on coagulation enzyme activity and platelet function.
The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation.
Used in conjunction with direct pressure, QuikClot ACS™ reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-Vivo testing on swine was performed at four different institutions: Hartford Hospital in Connecticut, Portsmouth Naval Hospital in Virginia, the Naval Medical Research Center (NMRC) in Maryland, and Uniformed Services University of the Health Sciences (USUHS) in Maryland. Tests demonstrated that the QuikClot ACS" product performs at least as well as the current granular product in the swine femoral artery model. A summary of the NMRC testing is included with this pre-market submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 11, 2023
Z-Medica Corporation Robert V. Packard QA Manager 4 Fairfield Boulevard Wallingford, Connecticut 06492
Re: K051955 Trade/Device Name: QuickClot ACSTM - "Advanced Clotting Sponge" Regulatory Class: Unclassified Product Code: QSY
Dear Robert V. Packard:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 10, 2005. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Image /page/0/Picture/7 description: The image shows the closing of a letter, including the sender's name and title. The letter is signed by Julie A. Morabito, Ph.D., who is the Assistant Director of DHT4B: Division of Infection Control and Plastic Surgery Devices. She also works in OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2005
Mr. Robert V. Packard QA Manager Z-Medica Corporation 4 Fairfield Boulevard Wallingford, Connecticut 06492
Re: K051955
Trade/Device Name: QuikClot ACS- "Advanced Clotting Sponge"™ Regulatory Class: Unclassified Product Code: FRO Dated: July 18, 2005 Received: July 19, 2005
Dear Mr. Packard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2- Mr. Robert V. Packard
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you're ough mailing of substantial equivalence of your device to a legally prematics notineadon: The PDF Amanissification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
StyL. Rhoda
Mark L. Mcllerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K021952 510(k) Number (if known):
Device Name: QuikClot ACS - "Advanced Clotting Sponge" ™
Indications For Use: QuikClot ACS - "Advanced Clotting Sponge" ™, is intended for emergency use only as an external traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styt Churly
Fision Sign-Off Division of General, Restorative and Neurological Devices
1 Page 1 of
Number K051955
4
KOS1955
7
14
AUG 1 0 2005
510(k) Summary
| Trade Name: | QuikClot ACSTM – “Advanced Clotting Sponge” |
|---|---|
| Device Class: | Class 1 |
| Classification Panel: | General and Plastic Surgery |
| Common Name: | Traumatic Wound Dressing |
| Classification Name: | Dressing |
| Classification Code: | FRO |
| Predicate Device: | QuikClot® Brand Hemostatic Granules |
| 510(k) No. K013390 | |
| Submitted By: | Robert V. Packard, QA Manager |
| Company Name: | Z-Medica Corporation |
| Company Address: | 4 Fairfield Blvd., Wallingford, CT 06492 |
| Company Phone: | (203) 294-0000 |
| Prepared: | July 18, 2005 |
Device Description
The new mesh bags containing beads of QuikClot® Brand Hemostatic Agent, also called QuikClot ACS™ - "Advanced Clotting Sponge", are intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss.
The beads inside the mesh bags consist of a synthetic molecular sieve (zeolite) that accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site. Individual sieve particles of the hemostatic agent adsorb water molecules. As the water is removed from the blood, the platelets and clotting factors are concentrated. The platelets have been activated by the normal response to injury. This adsorption process is exothermic. The resultant increase in temperature at the site of application increases the rate of the clotting reactions and platelet aggregation and adhesion.
Both of the mechanisms described above, concentration of clotting factors and the increase in rates of platelet aggregation/adhesion, work together to increase the clotting rate. This would be consistent with what is known about the effects of temperature and concentration on coagulation enzyme activity and platelet function.
The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation.
Used in conjunction with direct pressure, QuikClot ACS™ reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds.
In-Vivo testing on swine was performed at four different institutions: Hartford Hospital in Connecticut, Portsmouth Naval Hospital in Virginia, the Naval Medical
5
KOS1955
ાં ર
Research Center (NMRC) in Maryland, and Uniformed Services University of the Health Sciences (USUHS) in Maryland. Tests demonstrated that the QuikClot ACS" product performs at least as well as the current granular product in the swine femoral artery model. A summary of the NMRC testing is included with this pre-market submission.
This application for Special 510(k) clearance concerns the same hemostatic agent, in bead form, but the beads have been placed inside a synthetic mesh bag in order to facilitate easier application and removal of the product. This device modification retains the benefits of the previous device modification, granules vs. beads, but instead of removing individual beads from a wound medical personnel only need to remove the mesh bag containing the beads. Biocompatibility data for this device, and historical biocompatibility data for the components, is summarized in the appendices of this submission.
The intended use of the product remains the same, and the ACS product uses a similar method of application. Incorporation of the mesh bag presents some new potential failure modes for the device, but the Risk Analysis performed by the design development team indicates that the design and process controls used are sufficient to mitigate risks to an acceptable level and no additional actions are required. The risk analysis report for the ACS product is also included in the appendices of this submission.
QuikClot ACS" is a safe, effective, low cost traumatic wound dressing which is substantially alike in purpose, characteristic, process, and result to the QuikClot® Brand Hemostatic Granules, and thereby eligible for approval under 510(k).